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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029217
Receipt No. R000033398
Scientific Title Prospective study about preventive drainage tube placement at laparoscopic liver resection(Randomized Controlled Trial)
Date of disclosure of the study information 2017/09/20
Last modified on 2017/09/20

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Basic information
Public title Prospective study about preventive drainage tube placement at laparoscopic liver resection(Randomized Controlled Trial)
Acronym Drainage tube study at laparoscopic liver resection
Scientific Title Prospective study about preventive drainage tube placement at laparoscopic liver resection(Randomized Controlled Trial)
Scientific Title:Acronym Drainage tube study at laparoscopic liver resection
Region
Japan

Condition
Condition liver tumor
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For patients with liver tumor (hepatocellular carcinoma, metastatic liver cancer, benign tumor,etc.) adapted for laparoscopic hepatectomy (excluding biliary reconstruction, combined resection of other organs (excluding gallbladder excision)), comparison of short term results (within30 days)with and without preventive internal draining.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of incidence of adverse event correlated with liver resection(bile leakage, bleeding, thoracicoabdominal fluid, intra-abdominal abscess, wound infection:more than Grade2 of Clavien-Dindo classification)
Key secondary outcomes other adverse event, postoperative hospital stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 control group(drainage tube placement group)

Standards of treatment content
1)The type and number of drainage tube, the place of detention are not specified, but in principle the closed type drainage tube is used.
2)Criteria for withdrawal in drainage tube placement group:If the bilirubin level of drain fluid is less than 3 times the serum level around 3 days after surgery, it will be removed on the same day or the next day, the drain fluid level is not limited. When the drainage tube placement is extended, report the cause.
3)In cases where it is judged that drainage tube placement is necessary during operation after allocation to non drainage tube placement group, it is counted as non drainage tube placement group in which an adverse event occurred.
4)Diagnosis of bile leakage defines the bilirubin level of drain fluid to be more than 3 times the serum level. Leave it to the doctor in charge of each facility about the need for reoperation and additional drainage tube placement.
5)In case of laparotomy transition, protocol treatment is discontinued.
Interventions/Control_2 intervention group(non drainage tube placement group)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)A patient with liver tumor that is indicated for laparoscopic hepatectomy(except biliary reconstruction).
2)A patient who have obtained written consent from participants in this study.
3)PS:0-1(ECOG grade)
4)A Patient found to have the function of the main organs by clinical examination within 28 days before registration.
5)Child-Pugh classification:A or B
Key exclusion criteria 1)A patient scheduled for other organ resection(excluding gallbladder) as combined resection.
2)A Patient who left bile drainage tube(C tube etc) during operation.
3)A patient with severe complications as follows.
intestinal palsy, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, heart failure, renal failure, liver failure, active ulcer of the gastrointestinal tract and active varicose veins, severe psychiatric disorders and depressive state.
4)A patient who is pregnant, has a possibility of pregnancy, is breastfeeding.
5)In addition, it is judged that the examination responsible doctor or the test sharing doctor is inappropriate as the subject of this examination.
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Eguchi
Organization Graduate School of Medicine, Osaka University
Division name Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita 565-0871 Osaka, JAPAN
TEL 06-6879-3251
Email heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Noda
Organization Graduate School of Medicine, Osaka University
Division name Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita 565-0871 Osaka, JAPAN
TEL 06-6879-3251
Homepage URL
Email tnoda@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2017 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033398

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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